NCT00650975

Brief Summary

  1. 1.Assess whether excimer laser coronary atherectomy (ELCA) before direct infarct-related artery (IRA) stenting results in improved reperfusion success in patients presenting with acute ST wave elevation myocardial infarction (STEMI) and angiographically evident thrombus.
  2. 2.Validate an ELCA technique for the treatment of STEMI, at high-volume centers experienced in the treatment of acute myocardial infarction (AMI).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 20, 2011

Status Verified

January 1, 2011

First QC Date

March 26, 2008

Last Update Submit

January 19, 2011

Conditions

ST Elevation Acute Myocardial Infarction

Keywords

STEMILaserThrombusThrombectomy

Outcome Measures

Primary Outcomes (1)

  • Myocardial Blush Grade 3 (MBG3) ST-Resolution MACE

    60 minutes - 30 days

Study Arms (2)

ELCA

ACTIVE COMPARATOR

Laser Thromboablation

Device: Laser Thromboablation

PTCA

ACTIVE COMPARATOR

PTCA (Direct Stenting)

Device: PTCA (Direct Stenting)

Interventions

Laser ThromboablationDEVICE

Laser Thromboablation using the Spectranetics CVX-300® excimer laser system

ELCA
PTCA (Direct Stenting)DEVICE

Balloon predilatation or Direct Stenting using conventional techniques according to local standards and device specific instructions for use

Also known as: PCI, Direct Stenting
PTCA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • STEMI within 12 hours of symptom onset, with ≥ 2 mm ST segment elevation in two or more leads and minimum ≥ 3 mm ST segment elevation in one lead.
  • IRA is a native coronary artery; and,
  • Reference vessel diameter 2.5 - 4.0 mm; and,
  • TIMI 0 or 1 flow with any TIMI thrombus grade; or,
  • TIMI 2 or 3 flow with TIMI thrombus grade 3 or greater

You may not qualify if:

  • Patient unwilling or unable to give informed consent
  • Previous MI in the distribution of the current IRA
  • Previous CABG
  • Contraindications to PCI
  • allergy(s) to intended study medications
  • contraindicated for stent implantation
  • Active bleeding or coagulopathy
  • Patient in cardiogenic shock (\<90mmHg SBP and/or requiring IABP or vasopressors)
  • Known left ventricular ejection fraction (EF) \<30%
  • Fibrinolytic administered before PCI
  • Renal insufficiency (creatinine \>2.0mg/dl)
  • Current vitamin K antagonist therapy or known INR \>1.5
  • Known thrombocytopenia - platelets \<100,000 cell count
  • Patient has Left Bundle Branch Block (LBBB) or pacemaker rhythm
  • Known history of hemorrhagic stroke (CVA or TIA) \<2 years before screening
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Gornoslaskie Centrum Medyczne 3rd Dept of Cardiology

Katowice, 40-635, Poland

Location

Jagiellonian University College of Medicine, Institute of Cardiology John Paul II Hospital

Krakow, 31-202, Poland

Location

Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow

Krakow, 31-501, Poland

Location

University Hospital No. 1 1st Dept. of Cardiology

Poznan, 61-848, Poland

Location

Institute of Cardiology Hemodynamics dept., Cardiac Catheterization Laboratory

Warsaw, 04-628, Poland

Location

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionThrombosis

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisEmbolism and Thrombosis

Study Officials

  • Dariusz Dudek, MD, PhD

    Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2008

First Posted

April 2, 2008

Study Start

March 1, 2008

Study Completion

January 1, 2010

Last Updated

January 20, 2011

Record last verified: 2011-01

Locations

PL(5)